US20220142861A1 - Prescription medicine packaging system and method for using same to provide range of compliance options - Google Patents
Prescription medicine packaging system and method for using same to provide range of compliance options Download PDFInfo
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- US20220142861A1 US20220142861A1 US17/092,363 US202017092363A US2022142861A1 US 20220142861 A1 US20220142861 A1 US 20220142861A1 US 202017092363 A US202017092363 A US 202017092363A US 2022142861 A1 US2022142861 A1 US 2022142861A1
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- prescription medicine
- packaging system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
- A61J1/035—Blister-type containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
- A61J7/04—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
- A61J7/0409—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
- A61J7/0427—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system
- A61J7/0445—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system for preventing drug dispensing during a predetermined time period
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
- A61J7/04—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
- A61J7/0409—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
- A61J7/0454—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers for dispensing of multiple drugs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
- A61J7/04—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
- A61J7/0409—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
- A61J7/0481—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers working on a schedule basis
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H20/13—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered from dispensers
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
- G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J2200/00—General characteristics or adaptations
- A61J2200/30—Compliance analysis for taking medication
Definitions
- the invention relates generally to medicine packaging, and particularly to a packaging system for prescription medicine as well as a method for using the packaging system to satisfy a range of patient compliance options.
- Physicians prescribe medicines for their patients for a variety of conditions and diseases. In many cases, adherence to or compliance with a prescribed dosing regimen is critical for treatment efficacy and safety. For most patients, deviations from prescribed dosing requirements are of little concern. However, intentional or unintentional deviations from dosing requirements by patients with mental, emotional, or dependency issues can produce serious consequences.
- Another object of the present invention is to provide a prescription medicine packaging system that can satisfy the needs of patients not required to participate in a compliance program as well as those required to participate in a compliance program.
- Still another object of the present invention is to provide a prescription medicine packaging system that is cost effective.
- Yet another object of the present invention is to provide a prescription medicine packaging system that is readily adapted to existing prescription medicine packaging technologies.
- a still further object of the present invention is to provide a non-electronic prescription medicine packaging system for use in a patient compliance program.
- a prescription medicine packaging system includes a plurality of cells. Each cell stores prescription medicine. Each cell has an opening adapted for access by a user. A cap is aligned over and seals one cell opening. Each cap includes a first part and a second part. The first part and second part are independent of one another and are uniquely identifiable by features thereof. Each of the caps is breached via one of removal and destruction of one of its first part and second part.
- FIG. 1 is a plan view of a prescription medicine packaging system in accordance with an embodiment of the present invention
- FIG. 2 is a cross-sectional view of the embodiment in FIG. 1 taken along line 2 - 2 thereof;
- FIG. 3 is a cross-sectional view of a portion of a prescription medicine packaging system whose caps are incorporated into a sealing film in accordance with another embodiment of the present invention
- FIG. 4 is a cross-sectional view of a portion of a prescription medicine packaging system incorporating a tearable seal hidden beneath each cap in accordance with another embodiment of the present invention
- FIG. 5A is a plan view of a cap whose two parts are uniquely identifiable by color features
- FIG. 5B is a plan view of a cap whose two parts are uniquely identifiable by relief features
- FIG. 5C is a plan view of a cap whose two parts are uniquely identifiable by machine-readable features and visual character features;
- FIG. 6 is a plan view of a prescription medicine packaging system having a unique serial number assigned thereto that facilitates use of the packaging system in a prescription medicine compliance program in accordance with an embodiment of the present invention.
- FIG. 7 is a plan view of the prescription medicine packaging system illustrated in FIG. 6 as it would appear after a patient had completed a dosing regimen in accordance with an embodiment of the prescription medicine compliance program of the present invention.
- packaging system 10 is used for dispensing prescription medicines that are in a solid form to include tablets, capsules, caplets, etc., the choice of which is not a limitation of the present invention.
- packaging system 10 is configured for periodic (e.g., daily) dosing over the course of two weeks.
- periodic e.g., daily
- novel features of packaging system 10 can be applied to any dosing regimen without departing from the scope of the present invention.
- packaging system 10 includes a portion 20 that defines a plurality of cells 22 , each of which has an opening indicated by dashed lined 24 .
- Cells 22 can be coupled to or integrated with a base 26 that connects all cells 22 as is well understood in the art.
- portion 20 can be constructed as a conventional blister pack.
- Disposed in each cell 22 is prescription medicine for a patient.
- a cell 22 can contain a single dose of a medicine, multiple doses of a medicine, or multiple diverse medicines that are taken by a patient at a time of dosing.
- each cell 22 contains a single dose of a prescription medicine 100 in a solid form thereof.
- Each opening 24 is covered and sealed by a cap 30 coupled to base 26 .
- each cap 30 could be a film element adhered about its perimeter to base 26 .
- Each cap 30 is a multi-part cap structure having two or more parts that are independent of one another.
- cap 30 includes a first part 32 and a second part 34 .
- Parts 32 and 34 are fully integrated portions of cap 30 , but are independent of one another.
- parts 32 and 34 are configured for independent removal or destruction in a way that leaves the non-removed or non-destroyed part of the cap intact.
- part 32 when caps 30 are film elements, part 32 could be made independently removable along a score line 36 circumscribing part 32 , and part 34 could be made independently removable along a score line 38 circumscribing part 34 .
- scoring of film elements for removal of parts thereof is well understood in the art.
- Parts 32 and 34 can be similarly or uniquely shaped, and/or can be rectangular (as shown) but could also be other geometric shapes (e.g., circles, triangles, etc.) without departing from the scope of the present invention.
- Each of parts 32 and 34 incorporates uniquely identifiable feature(s) on its exposed surface, i.e., on the surface thereof facing away from its cell 22 .
- the uniquely identifiable features are alphanumeric characters 33 on part 32 and alphanumeric characters 35 on part 34 .
- the alphanumeric characters could specify the number of the dose in the regimen (i.e., 1 , 2 , 3 , etc.) and the first or second part of the cap (i.e., A or B).
- Access to a cell 22 and its stored dose 100 can be achieved by removal and/or destruction of a cap's part 32 and/or the cap's part 34 .
- packaging system 10 can be used in a conventional manner without the need for any special instructions. That is, it does not matter if a patient accesses a cell 22 by removal/destruction of one or both of parts 32 and 34 .
- packaging system 10 can also be used as part of a prescription medicine compliance program as will be explained later below.
- FIG. 3 another embodiment of a prescription medicine packaging system in accordance with the present invention is shown in a cross-sectional view similar to that shown in FIG. 2 .
- portion 20 has its base 26 and opening 24 completely covered by an overlay (e.g., a film) 40 having the above-described caps 30 integrated into overlay 40 .
- overlay 40 e.g., a film
- caps 30 has its independent and uniquely identifiable first part and second part 34 associated therewith as described above.
- the present invention can also include additional child safety features as illustrated in the embodiment shown in FIG. 4 where a cross-sectional view similar to that shown in FIG. 2 is shown.
- overlay 40 defining caps 30 is coupled to portion 20 as described above.
- each cell 22 has a tearable material 28 spanning the cell and sealed to the side walls thereof.
- Each tearable material 28 is disposed beneath a corresponding opening 24 such that a chamber 29 is defined between a corresponding cap 30 and tearable material 28 .
- cell 22 In order to dispense dose 100 , cell 22 must be pressed such that dose 100 tears or ruptures material 28 so that dose 100 is pressed into chamber 29 where it can then be accessed as described above. The extra step required to access dose 100 provides for child safety.
- FIG. 5A illustrates a cap 30 whose first part 32 is one color and second part 34 is a distinct color from that used for part 32 .
- FIG. 5B illustrates a cap 30 whose first part 32 has a unique relief element (e.g., a Braille letter) as compared to the relief element on second part 34 .
- part 32 presents the Braille symbol referenced by numeral 33 A for the letter “a”
- part 34 presents the Braille symbol referenced by numeral 35 A for the letter “b”.
- FIG. 5C illustrates the use of a combination of a machine-readable QR code 33 C and alphanumeric characters 33 on part 32 , and a QR code 35 C and alphanumeric characters 35 on part 34 .
- the packaging system of the present invention can be used to dispense medicine to a patient that presents no dosing compliance concerns.
- the present invention can also be used as an integral part of a unique prescription medicine compliance program in an effort to monitor a patient's compliance with a dosing regimen.
- the essential features of such a compliance program will be explained with reference to FIGS. 6 and 7 where the above-described packaging system 10 ( FIGS. 1 and 2 ) is modified and referenced generally by numeral 50 to include a unique serial number 52 assigned during manufacture or when the packaging system is provided to a patient.
- Packaging system 50 is activated when serial number 52 is logged into a database (not shown) when it is provided to a user/patient.
- a variety of ways of assigning serial number 52 and the activating of packaging system 50 can be achieved in a variety of ways without departing from the scope of the present invention.
- a notification system in accordance with the present invention is implements to issue periodic notifications to the patient governing dispensing of the prescription medicine for each dose or each day as is warranted.
- each notification specifies which part of a cap 30 (i.e., either part 32 or part 34 ) is to be removed or destroyed to provide access to a cell of the packaging system so that a prescription medicine dose can be dispensed.
- a notification can be issued to the patient specifying that the patient should remove part 34 (i.e., identified by “1B”) to gain access to the dose of medicine.
- part 32 with “1A” thereon remains intact and identifiable.
- the issuance of the periodic notifications can be accomplished in a variety of ways without departing from the scope of the present invention.
- the periodic notifications could be sent automatically to one or both of the patient's phone and e-mail address.
- the notifications can also be sent using other forms of wired or wireless communication systems without departing from the scope of the present invention.
- a patient could be required to request a notification each day or at time of dosing. For example, a patient could call, text, or e-mail their serial number 52 to a central location that would then issue the next notification.
- FIG. 7 illustrates packaging system 50 at the completion of a dosing regimen whose periodic notifications were as follows:
- Deviations from the expected pattern can be used as a treatment tool to help a patient achieve full compliance for treatment efficacy and safety.
- recording and/or evaluation of a package's remaining identifiable cap parts can be required daily, on a random basis, and/or when a dosing regimen is completed such that all cells of a packaging system are empty.
- the advantages of the present invention are numerous.
- the simple packaging system can be used for any patient to include those who may need to have their dosing regimen reported and/or monitored as part of a compliance program.
- the packaging system empowers the patient with simple dosing access notification. Since the exact same packaging system can be used for patients requiring no compliance as well as those requiring compliance, there is no stigma attached to patients requiring compliance.
- the packaging system requires no electronics and, therefore, is a cost-effective solution to compliance monitoring.
- the system can be readily incorporated into existing blister pack technology thereby speeding its implementation and minimizing the need for a patient to familiarize themselves to a new type of packaging technology.
- each cap in the present invention can comprise three or more independent parts without departing from the scope of the present invention. It is therefore to be understood that, within the scope of the appended claims, the invention may be practiced other than as specifically described.
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Abstract
Description
- The invention relates generally to medicine packaging, and particularly to a packaging system for prescription medicine as well as a method for using the packaging system to satisfy a range of patient compliance options.
- Physicians prescribe medicines for their patients for a variety of conditions and diseases. In many cases, adherence to or compliance with a prescribed dosing regimen is critical for treatment efficacy and safety. For most patients, deviations from prescribed dosing requirements are of little concern. However, intentional or unintentional deviations from dosing requirements by patients with mental, emotional, or dependency issues can produce serious consequences.
- To address these concerns, a variety of “smart” prescription medicine packaging systems have been developed. Many of these systems involve the inclusion of electronic sensors and/or transmitters that function as part of a monitoring system to track a patient's compliance with dosing requirements. However, given that prescription medicine packaging systems are discarded after use, the costs of such packaging systems is generally prohibitive, especially if they were to be instituted “across the board” for all types of patients.
- Accordingly, it is an object of the present invention to provide a prescription medicine packaging system.
- Another object of the present invention is to provide a prescription medicine packaging system that can satisfy the needs of patients not required to participate in a compliance program as well as those required to participate in a compliance program.
- Still another object of the present invention is to provide a prescription medicine packaging system that is cost effective.
- Yet another object of the present invention is to provide a prescription medicine packaging system that is readily adapted to existing prescription medicine packaging technologies.
- A still further object of the present invention is to provide a non-electronic prescription medicine packaging system for use in a patient compliance program.
- Other objects and advantages of the present invention will become more obvious hereinafter in the specification and drawings.
- In accordance with the present invention, a prescription medicine packaging system includes a plurality of cells. Each cell stores prescription medicine. Each cell has an opening adapted for access by a user. A cap is aligned over and seals one cell opening. Each cap includes a first part and a second part. The first part and second part are independent of one another and are uniquely identifiable by features thereof. Each of the caps is breached via one of removal and destruction of one of its first part and second part.
- Other objects, features and advantages of the present invention will become apparent upon reference to the following description of the preferred embodiments and to the drawings, wherein corresponding reference characters indicate corresponding parts throughout the several views of the drawings and wherein:
-
FIG. 1 is a plan view of a prescription medicine packaging system in accordance with an embodiment of the present invention; -
FIG. 2 is a cross-sectional view of the embodiment inFIG. 1 taken along line 2-2 thereof; -
FIG. 3 is a cross-sectional view of a portion of a prescription medicine packaging system whose caps are incorporated into a sealing film in accordance with another embodiment of the present invention; -
FIG. 4 is a cross-sectional view of a portion of a prescription medicine packaging system incorporating a tearable seal hidden beneath each cap in accordance with another embodiment of the present invention; -
FIG. 5A is a plan view of a cap whose two parts are uniquely identifiable by color features; -
FIG. 5B is a plan view of a cap whose two parts are uniquely identifiable by relief features; -
FIG. 5C is a plan view of a cap whose two parts are uniquely identifiable by machine-readable features and visual character features; -
FIG. 6 is a plan view of a prescription medicine packaging system having a unique serial number assigned thereto that facilitates use of the packaging system in a prescription medicine compliance program in accordance with an embodiment of the present invention; and -
FIG. 7 is a plan view of the prescription medicine packaging system illustrated inFIG. 6 as it would appear after a patient had completed a dosing regimen in accordance with an embodiment of the prescription medicine compliance program of the present invention. - Referring now to the drawings, simultaneous reference will be made to
FIGS. 1 and 2 where a prescription medicine packaging system is shown and is referenced generally bynumeral 10. In general,packaging system 10 is used for dispensing prescription medicines that are in a solid form to include tablets, capsules, caplets, etc., the choice of which is not a limitation of the present invention. Similarly, the type of prescription medicine is not a limitation of the present invention. In the illustrated example,packaging system 10 is configured for periodic (e.g., daily) dosing over the course of two weeks. However, it is to be understood that the novel features ofpackaging system 10 can be applied to any dosing regimen without departing from the scope of the present invention. - One of the great advantages of the present invention is its ready adaptability to existing prescription medicine packaging technologies. For example, the present invention can be used with existing blister pack technologies that are used extensively for dispensing prescription medicines. With reference now to
FIG. 2 ,packaging system 10 includes aportion 20 that defines a plurality ofcells 22, each of which has an opening indicated by dashed lined 24.Cells 22 can be coupled to or integrated with abase 26 that connects allcells 22 as is well understood in the art. For example,portion 20 can be constructed as a conventional blister pack. Disposed in eachcell 22 is prescription medicine for a patient. For example, acell 22 can contain a single dose of a medicine, multiple doses of a medicine, or multiple diverse medicines that are taken by a patient at a time of dosing. For simplicity of illustration and for purposes of the remainder of the description, eachcell 22 contains a single dose of aprescription medicine 100 in a solid form thereof. - Each
opening 24 is covered and sealed by acap 30 coupled tobase 26. For example, eachcap 30 could be a film element adhered about its perimeter tobase 26. Eachcap 30 is a multi-part cap structure having two or more parts that are independent of one another. By way of an illustrative example,cap 30 includes afirst part 32 and asecond part 34.Parts cap 30, but are independent of one another. Specifically,parts caps 30 are film elements,part 32 could be made independently removable along ascore line 36 circumscribingpart 32, andpart 34 could be made independently removable along ascore line 38circumscribing part 34. Such scoring of film elements for removal of parts thereof is well understood in the art.Parts - Each of
parts cell 22. In the illustrated example, the uniquely identifiable features arealphanumeric characters 33 onpart 32 andalphanumeric characters 35 onpart 34. For example, the alphanumeric characters could specify the number of the dose in the regimen (i.e., 1, 2, 3, etc.) and the first or second part of the cap (i.e., A or B). - Access to a
cell 22 and itsstored dose 100 can be achieved by removal and/or destruction of a cap'spart 32 and/or the cap'spart 34. For patients that are not at risk for dosing deviation problems,packaging system 10 can be used in a conventional manner without the need for any special instructions. That is, it does not matter if a patient accesses acell 22 by removal/destruction of one or both ofparts packaging system 10 can also be used as part of a prescription medicine compliance program as will be explained later below. - Referring now to
FIG. 3 , another embodiment of a prescription medicine packaging system in accordance with the present invention is shown in a cross-sectional view similar to that shown inFIG. 2 . In theFIG. 3 embodiment,portion 20 has itsbase 26 andopening 24 completely covered by an overlay (e.g., a film) 40 having the above-describedcaps 30 integrated intooverlay 40. Each ofcaps 30 has its independent and uniquely identifiable first part andsecond part 34 associated therewith as described above. - The present invention can also include additional child safety features as illustrated in the embodiment shown in
FIG. 4 where a cross-sectional view similar to that shown inFIG. 2 is shown. In theFIG. 4 embodiment,overlay 40 definingcaps 30 is coupled toportion 20 as described above. In addition, eachcell 22 has atearable material 28 spanning the cell and sealed to the side walls thereof. Eachtearable material 28 is disposed beneath acorresponding opening 24 such that achamber 29 is defined between acorresponding cap 30 andtearable material 28. In order to dispensedose 100,cell 22 must be pressed such thatdose 100 tears orruptures material 28 so thatdose 100 is pressed intochamber 29 where it can then be accessed as described above. The extra step required to accessdose 100 provides for child safety. - The uniquely identifiable features of
parts FIG. 5A illustrates acap 30 whosefirst part 32 is one color andsecond part 34 is a distinct color from that used forpart 32.FIG. 5B illustrates acap 30 whosefirst part 32 has a unique relief element (e.g., a Braille letter) as compared to the relief element onsecond part 34. In the illustrated example,part 32 presents the Braille symbol referenced by numeral 33A for the letter “a” andpart 34 presents the Braille symbol referenced by numeral 35A for the letter “b”.FIG. 5C illustrates the use of a combination of a machine-readable QR code 33C andalphanumeric characters 33 onpart 32, and aQR code 35C andalphanumeric characters 35 onpart 34. - As mentioned above, the packaging system of the present invention can be used to dispense medicine to a patient that presents no dosing compliance concerns. However, the present invention can also be used as an integral part of a unique prescription medicine compliance program in an effort to monitor a patient's compliance with a dosing regimen. The essential features of such a compliance program will be explained with reference to
FIGS. 6 and 7 where the above-described packaging system 10 (FIGS. 1 and 2 ) is modified and referenced generally by numeral 50 to include a uniqueserial number 52 assigned during manufacture or when the packaging system is provided to a patient.Packaging system 50 is activated whenserial number 52 is logged into a database (not shown) when it is provided to a user/patient. A variety of ways of assigningserial number 52 and the activating ofpackaging system 50 can be achieved in a variety of ways without departing from the scope of the present invention. - Once a patient has been provided with
packaging system 50 and it has been activated, a notification system in accordance with the present invention is implements to issue periodic notifications to the patient governing dispensing of the prescription medicine for each dose or each day as is warranted. In general, each notification specifies which part of a cap 30 (i.e., eitherpart 32 or part 34) is to be removed or destroyed to provide access to a cell of the packaging system so that a prescription medicine dose can be dispensed. For example, on “Day 1” of “Week 1”, a notification can be issued to the patient specifying that the patient should remove part 34 (i.e., identified by “1B”) to gain access to the dose of medicine. As a result,part 32 with “1A” thereon remains intact and identifiable. This process is repeated throughout the prescription regimen. That is, for purpose of patient compliance, a patient must wait for each dosage's notification prior to gaining access to a cell and its contained dose. In the illustrated example, after 14 days, the remaining and identifiable ones ofparts caps 30 will properly correspond to the caps' parts that should be identifiable. - The issuance of the periodic notifications can be accomplished in a variety of ways without departing from the scope of the present invention. For example, if
serial number 52 is associated with a patient's phone number and/or e-mail address, the periodic notifications could be sent automatically to one or both of the patient's phone and e-mail address. The notifications can also be sent using other forms of wired or wireless communication systems without departing from the scope of the present invention. In other embodiments of a compliance program in accordance with the present invention, a patient could be required to request a notification each day or at time of dosing. For example, a patient could call, text, or e-mail theirserial number 52 to a central location that would then issue the next notification. - As mentioned above, at the conclusion of a prescription medicine regimen,
packaging system 50 should have half of its caps' parts removed with the other half of the caps' parts remaining intact and identifiable. By way of an illustrative example,FIG. 7 illustratespackaging system 50 at the completion of a dosing regimen whose periodic notifications were as follows: -
- Week 1: 1B, 2B, 3A, 4A, 5A, 6B, 7A
- Week 2: 8A, 9B, 10B, 11B, 12A, 13A, 14B
The remaining identifiable pattern of intact cap parts can be recorded and associated withserial number 52 as a compliance check.
- Deviations from the expected pattern can be used as a treatment tool to help a patient achieve full compliance for treatment efficacy and safety. Depending on the needs of the patient and/or the nature of the medicine being dispensed, recording and/or evaluation of a package's remaining identifiable cap parts can be required daily, on a random basis, and/or when a dosing regimen is completed such that all cells of a packaging system are empty.
- The advantages of the present invention are numerous. The simple packaging system can be used for any patient to include those who may need to have their dosing regimen reported and/or monitored as part of a compliance program. For cases where compliance is required, the packaging system empowers the patient with simple dosing access notification. Since the exact same packaging system can be used for patients requiring no compliance as well as those requiring compliance, there is no stigma attached to patients requiring compliance. The packaging system requires no electronics and, therefore, is a cost-effective solution to compliance monitoring. The system can be readily incorporated into existing blister pack technology thereby speeding its implementation and minimizing the need for a patient to familiarize themselves to a new type of packaging technology.
- Although the invention has been described relative to a specific embodiment thereof, there are numerous variations and modifications that will be readily apparent to those skilled in the art in light of the above teachings. For example and as mentioned above, each cap in the present invention can comprise three or more independent parts without departing from the scope of the present invention. It is therefore to be understood that, within the scope of the appended claims, the invention may be practiced other than as specifically described.
- What is claimed as new and desired to be secured by Letters Patent of the United States is:
Claims (22)
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Application Number | Priority Date | Filing Date | Title |
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US17/092,363 US11759393B2 (en) | 2020-11-09 | 2020-11-09 | Prescription medicine packaging system and method for using same to provide range of compliance options |
PCT/US2021/010045 WO2022098379A1 (en) | 2020-11-09 | 2021-11-09 | Prescription medicine packaging system and method for using same to provide range of compliance options |
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US17/092,363 US11759393B2 (en) | 2020-11-09 | 2020-11-09 | Prescription medicine packaging system and method for using same to provide range of compliance options |
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US5325968A (en) * | 1993-07-14 | 1994-07-05 | Mcneil-Ppc, Inc. | Package for holding tablets |
US6691870B1 (en) * | 1999-07-07 | 2004-02-17 | Lts Lohmann Therapie-Systeme Ag | Blister box pack for sensitive packaged goods with highly volatile and/or moisture sensitive components |
US7121409B1 (en) * | 1999-09-02 | 2006-10-17 | Snap Pak Industries (Aust) Pty Ltd. | Dispensing sachet by bending and method of sachet manufacture |
US20030213721A1 (en) * | 2002-05-14 | 2003-11-20 | Marty Jones | Peel away tab child resistant package |
US20040182739A1 (en) * | 2003-03-20 | 2004-09-23 | Williams-Hartman Wade Everelle | Child-resistant and senior-friendly blister card package |
US9216850B2 (en) * | 2006-09-26 | 2015-12-22 | Intercontinental Great Brands Llc | Rupturable substrate |
US20190282503A1 (en) * | 2006-11-09 | 2019-09-19 | Nalpropion Pharmaceuticals, Inc. | Methods For Administering Weight Loss Medications |
US20110162330A1 (en) * | 2007-10-31 | 2011-07-07 | Gary Paul Cotton | Systems and methods for child-resistant and senior friendly packaging |
US20130256183A1 (en) * | 2009-12-09 | 2013-10-03 | Amcor Flexibles, Inc. | Child Resistant Blister Package |
US20150021224A1 (en) * | 2011-01-05 | 2015-01-22 | Ziba Labs Llc | Packaging with pre-formed plastic web including user-graspable tear tab |
US20150096920A1 (en) * | 2012-10-08 | 2015-04-09 | The Procter & Gamble Company | Child-Resistant Blister Package |
US9717650B2 (en) * | 2014-02-28 | 2017-08-01 | Multi Packaging Solutions Uk Limited | Child resistant packaging |
US9375384B2 (en) * | 2014-11-26 | 2016-06-28 | 62770 Manitoba Ltd | Medication compliance package with hand hole |
US20200165045A1 (en) * | 2017-06-20 | 2020-05-28 | Asahi Kasei Kabushiki Kaisha | Lid material for press-through packages |
US11478404B2 (en) * | 2019-03-22 | 2022-10-25 | Hazen Paper Company | Method of protecting security elements from heat degradation during a heat-sealing process |
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US11759393B2 (en) | 2023-09-19 |
WO2022098379A1 (en) | 2022-05-12 |
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